Kornimate/medical-research-clean huggingface dataset:
effects of green tea extract on obese women with high level of ldl

Conditions: Obese; Hyperlipidemia

Summary: green tea is one of the most popular beverages in the world. it is believed to have beneficial effect in prevention and treatment of many diseases, one of which is reducing ldl-c. the aim of the study is to examine the effect of supplement containing gte on obese with high ldl level.

randomized, double-blind, crossover placebo-controlled clinical trial

Eligibility criteria:
inclusion criteria: 1. age between 18 and 65 years 2. body mass index (bmi) \>= 27 kg/m2 3. fasting low-density-lipoprotein cholesterol (ldl) \>= 130mg/dl and (4) willing to participate in this trial. exclusion criteria: 1. serum alanine transaminase \> 80 u/l 2. serum creatinine \> 1.8 mg/dl 3. breast feeding or pregnancy 4. heart failure, acute myocardial infarction, stroke, heavy injury 5. any other conditions not suitable for trial as evaluated by the physician. -

Keywords: obese women high ldl-c
german multicenter trial for the treatment of newly diagnosed t-lymphoblastic lymphoma in adults

Conditions: Lymphoma, Lymphoblastic

Summary: this study evaluates the efficacy and tolerability of treatment for t-lymphoblastic lymphoma (t-lbl) according to a protocol for acute lymphoblastic leukemia. patients receive one year of intensive cyclical chemotherapy with additional prophylaxis for central nervous system (cns) relapse by intrathecal therapy and cranial irradiation and mediastinal irradiation after induction chemotherapy.


Eligibility criteria:
inclusion criteria: * t-lymphoblastic lymphoma (bone marrow \[bm\] involvement \< 25%) * aged 15-65 years (55-65 years if biologically younger) * written informed consent exclusion criteria: * severe complications due to lymphoma or secondary disease * t-lbl as second malignancy or other active second malignancy * cytostatic pretreatment of lbl (exception of emergency treatments) * pregnancy * severe psychiatric illness or other circumstances which may compromise cooperation of the patient or informed consent * participation in other study interfering with study treatment

Keywords: t-lbl treatment de novo chemotherapy adult lymphoma, lymphoblastic, t-cell
treatment and rehabilitation of patients with hip arthroplasty to regain walk and work efficiency and quality of life

Conditions: Osteoarthritis, Hip

Summary: the aim of the study is to improve hospital treatment and rehabilitation of patients with hip arthroplasty to help the patients to regain functional ability in the shortest possible time, and reduce hospital and rehabilitation time to save costs for the patient and society. optimal reconstruction of the hip joint and the effect of an intensive physical training programme are compared to conventional rehabilitation programmes.


Eligibility criteria:
inclusion criteria: * primary osteoarthritis * unilateral osteoarthritis * age below 65 yrs * asa group 1-2 exclusion criteria: * pregnancy * age below 18 yrs * cardiovascular disease * diseases in the musculoskeletal system that could influence on training
efficacy of different acupuncture methods for chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with chronic low back pain and to compare 2 different groups of patients which differ in the acupuncture method used to treat the pain.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic low back pain (for at least 3 months) confirmed by a consultant * indication for treatment of low back pain with acupuncture confirmed by a consultant * at least 40 mm on a vas pain scale exclusion criteria: * acupuncture during the last 6 months * start of a new therapy for low back pain within the last 4 weeks * pregnancy * substance or drug abuse

Keywords: low back pain acupuncture
safety study of high-dose ranibizumab for polypoidal choroidal vasculopathy

Conditions: Polypoidal Choroidal Vasculopathy

Summary: monthly, continuous anti-vegf therapy for patients presenting with active polypoidal choroidal vasculopathy. two arms, treatment naive and previously treated with an fda approved anti-vegf therapy, will be randomized and dosed with open label 2.0mg ranibizumab.

patients will be followed with spectral oct, 4m bcva, icg, fa and monthly eye examinations for one year.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age \>= 25 years * polypoidal choroidal vasculopathy as noted on fluorescein and icg angiography: active leakage, active bleeding or recent decrease in vision * bvca using etdrs of 20/32 to 20/400 exclusion criteria: * any history of prior vitrectomy * any prior treatment with verteporfin pdt in the study eye * previous cataract surgery within the preceding 2 months of d0 * active intraocular inflammation in the study eye * active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * a condition, that in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease) * participation in another investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry. * prior anti-vegf (macugen, avastin, lucentis) in the study eye within 30 days prior to enrollment in this study * known allergy to any component in the study drug * uncontrolled hypertension: \>180/110 * major surgery within 28 days prior to randomization * myocardial infarction, other cardia events requiring hospitalization within 6 months prior to randomization * systemic anti-vegf or pro-vegf within 3 months of randomization * pregnancy or lactation * history of recurrent significant infections or bacterial infections

Keywords: pcv polypoidal choroidal vasculopathy
compass hinge stabilization of knee dislocations: a randomized trial

Conditions: Knee Dislocation

Summary: the purpose of this project is to evaluate the effect of the compass™ universal hinge external fixator on the outcome of patients following acute dislocation of the knee

prospective randomized outcome study. patients will be randomized either into the control group (group a) or the study group (group b) based on a computer generated randomization table. both groups will undergo an identical surgical protocol, as outlined below. the only difference is that patients in group a will have a range of motion external brace placed following surgery, while patients in group b will have a ckh placed. the rehabilitation protocol for the two groups will be identical, as outlined below. both groups will undergo an anterior cruciate ligament (acl) reconstruction on a delayed basis two months following surgery, if the acl was torn during the knee dislocation. the acl reconstruction will be delayed in both groups if a minimum range of motion of 10-90 degrees has not been attained. surgical protocol : approximately 10 - 21 days following the injury, patients will undergo the first surgical procedure on their knee dislocation. during the first procedure, they will have a posterior cruciate ligament (pcl) reconstruction using an achilles tendon allograft, with the direct onlay, two bundle technique. additionally, any damage to either the posterior medial or posterior lateral corner will be repaired (not reconstructed), and any meniscus pathology will be addressed. the final step of this first procedure will be applying the ckh to patients randomized to the compass group (the alignment pins will be placed prior to repair of the corner). patients will undergo an acl reconstruction (if necessary) approximately 8 weeks following the initial surgery, when the ckh will be removed. additional surgeries will be performed on patients to treat motion problems/arthrofibrosis as well as recurrent instability on an "as-needed basis." rehabilitation protocol - aggressive rehabilitation will be started on the day following surgery. patients will be placed in continuous passive motion (cpm) machines with an initial range of motion of 0 - 30 degrees. the hinge will be locked into full extension for at least 4 hours per day. we will continue cpm for two weeks, with a goal of increasing by at least 10 degrees per day to 90 degrees of flexion. weightbearing will be allowed as tolerated with the hinge locked in extension.

Eligibility criteria:
inclusion criteria: * trauma patient with a knee dislocation that requires surgical repair * adult patient (19 years and older) exclusion criteria: * patients unable or unwilling to comply with follow-up gait, radiographic and clinical evaluations necessary to complete the study * patients unable or unwilling to give informed consent and/or who have no responsible family member willing to give consent * pregnant women * prisoners

Keywords: orthopaedic trauma knee dislocation compass hinge external fixator external brace
patient-related effects of primary nursing

Conditions: Nurse's Role

Summary: after a one-year phase of development, primary nursing (process-responsible nursing; pp) has been practically implemented on a pilot icu since january 2022 at the heart and diabetes center nrw. pp plan, coordinate and evaluate the nursing carried out. in the further course, an examination between the project icu and another icu without pp with a focus on thoracic and cardiovascular surgery (surgical icu) is to be carried out. the primary goal of this pilot study is to test the feasibility of a large-scale rct with patient-related outcomes.

after a one-year phase of development, primary nursing (process-responsible nursing; pp) has been practically implemented on a pilot icu since january 2022 at the heart and diabetes center nrw. previously, the system of room care (standard care) was carried out. pp plan, coordinate and evaluate the nursing carried out. in addition, they take on the care responsibility for a maximum of two patients and also carry out the care at the same time. in the further course, an examination between the project icu and another icu with a focus on thoracic and cardiovascular surgery (surgical icu) is to be carried out. the primary goal of this pilot study is to test the feasibility of a large-scale rct. for this purpose, the duration of delirium after the introduction of a pp on the project icu should be compared with the previous care organization as standard care in a surgical icu. secondary goals e.g. include: the incidence of delirium, anxiety, as well as the satisfaction of the relatives and the effects of pp on nurses are shown.

Eligibility criteria:
inclusion criteria: * all patients are included who are at least 65 years old, * understand german language, * whose health insurance company has concluded a quality contract with the heart and diabetes center nrw (hdz nrw), * elective thoracic and cardiovascular surgery, * intensive care for at least three days on icu. relatives: * at least 18 years old, * patients have to receive pp. focus group interview with nurses of the intervention-icu: * nurses have to be at least 18 years old, * nurses belong the the intervention-icu. exclusion criteria: patients who * are \< 65 years old, * whose health insurance company has not concluded a quality contract with the hdz nrw, * cannot be admitted due to allocation by randomization and a lack of free bed on the destination icu, * have not given their informed consent, * cannot participate in the cam-icu screening due to neurological diseases, * in whom the screening using cam-icu could not be carried out over the entire intensive care stay and/or * belong to the target group but stay less than three days after their elective operation in the icu. relatives: * not at least 18 years old and/or * the patients do not receive pp. focus group interview with nurses of the intervention-icu: * nurses who are not at least 18 years old and * nurses do not belong to the intervention-icu.

Keywords: delirium intensive care units primary nursing professional practice
cevus with intravesical administration of optison tm (trademark) in children

Conditions: Vesico-Ureteral Reflux

Summary: in this clinical trial the investigators aim to evaluate the diagnostic feasibility and safety of cevus with the intravesical use of optison for vesicoureteral reflux detection and urethral imaging in children.

contrast enhanced voiding urosonography (cevus) is a radiation free, highly sensitive imaging modality for vesicoureteral reflux (vur) and urethral imaging in children. it employs ultrasound technology in combination with ultrasound contrast agent, which is administered intravesically via a bladder catheter. currently, second generation ultrasound contrast agents are commercially available, comprising of gas-filled microbubbles. cevus in children is being widely practiced, primarily in europe, despite the fact that none of the commercially available ultrasound contrast agents are yet approved for clinical applications in pediatric population. in the united states, there is limited clinical experience with cevus in children. among the currently commercially available ultrasound contrast agents, optison has already been used in research and off-label in clinical settings involving adults and children. one in-vitro study has been conducted aiming to optimize the ultrasound technical parameters and the dose of optison for intravesical administration in children. in this clinical trial the investigators aim to evaluate the diagnostic feasibility and safety of cevus with the intravesical use of optison for vesicoureteral reflux detection and urethral imaging in children.

Eligibility criteria:
inclusion criteria: 1. children 2-18 years (first age cohort). 2. children 0-18 years (second age cohort). 3. referred to the children's hospital of philadelphia (chop) for the performance of the clinically indicated voiding cystourethrography (vcug) examination. 4. parental/guardian permission (informed consent) and if appropriate, child's assent for additional performance of contrast enhanced voiding urosonography (cevus) examination. exclusion criteria: 1. hypersensitivity to perflutren, blood, blood products or albumin. 2. children requiring sedation for vcug or cevus examinations. 3. parents/guardians or subjects who, in the opinion of the principal investigator, may be non-compliant with study schedules or procedures.

Keywords: ultrasound ultrasound contrast agents optison contrast enhanced voiding urosonography (cevus) cevus vesicoureteral reflux children kidney bladder urethra voiding cystourethrography (vcug) vcug safety urinary tract
probiotics supplementation in premature infants

Conditions: Prematurity

Summary: the main objective is to assess the nutritional benefit of probiotics supplementation on premature infants growth. as secondary objectives, different parameters related to probiotics tolerance will be measured.


Eligibility criteria:
inclusion criteria * gestational age between 26 weeks and 31 weeks * birth weight between 700 to 1600 g * eutrophic infants (weight between -2 to 2 ds, usher curves) * admitted to one of the participating hospital unit within the 8 days following the birth, the birth date equals the 1st day of life. * still on parenteral feeding or infusion on the 5th day of birth non inclusion criteria * digestive disorders \> or equal to 1b on bell stage * severe intra-ventricular haemorrhage (stage 3-4) before 5th day of life. * severe malformations or digestive malformations * no antenatal corticosteroid therapy * severe medical or surgical disorder affecting the absorption, digesting and as a result the growth (hirschsprung disease, lactose intolerance, cow milk protein allergy, mucoviscidosis). * parents geographical distance preventing the hospitalization follow-up in the hospital participating unit (geographical distance planned before the infant reaches 1500 g or 32 weeks of gestational age) exclusion criteria * enteral/oral feeding termination during more than 72 hours due to severe digestive disorders (\> or equal to 2a on bell stage ) * serious digestive surgery

Keywords: prematurity nutrition growth
an exploratory study to assess multiple doses of omalizumab in patients with cystic fibrosis complicated by acute bronchopulmonary aspergillosis (abpa)

Conditions: Cystic Fibrosis; Allergic Bronchopulmonary Aspergillosis

Summary: this study will evaluate the safety and efficacy of omalizumab for the treatment of allergic bronchopulmonary aspergillosis (abpa) in patients with cystic fibrosis aged 12 years and older.


Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis complicated by allergic bronchopulmonary aspergillosis (abpa) * oral corticosteroid use for abpa flare * age 12 years and older (except for italy; ≥ 18 years) * total serum ige levels ≥ 500 iu/ml exclusion criteria: * history of cancer in the last 10 years. * history of severe allergic reactions * pregnant and lactating women * prior use of xolair other protocol-defined inclusion/exclusion criteria may apply.

Keywords: cystic fibrosis allergic bronchopulmonary aspergillosis omalizumab oral corticosteroid use anti-immunoglobulin e
associated balance of risk score - comprehensive complication index for the prediction of post-transplant survival

Conditions: Liver Cirrhosis; Liver Failure; Liver Diseases; Transplant Failure

Summary: in recent years, several scoring systems have been developed aimed at predicting early post-lt graft function. however, many of them showed poor efficacy when long-term survivals were tested. moreover, the necessity to find an easy-to-use score represents another obstacle, with several scores composed by numerous, difficult to find, variables. recently, the pre-lt balance of risk (bar) and the post-lt comprehensive complication index (cci) have been created, but their external validation and integration in this setting is lacking. this study aims at constructing an easy-to-use score system based on the combination of a small number of pre- and immediately post-liver transplant (lt) independent variables, in order to accurately predict long-term graft survival after lt.

in the last years, several scoring systems have been developed with the intent to predict waiting-list mortality or early allograft dysfunction (ead) after liver transplantation (lt). the model for end-stage liver disease (meld) is recognised as the most accurate liver allograft allocation model by prioritising patients according to the severity of their disease. however, several studies showed that meld alone failed to predict early and late post-transplant clinical course. consequently, other scoring systems based on pre-lt or post-lt variables have been developed, with the intent to identify high-risk cases for death, graft loss or re-transplantation (re-lt). among them, two pre-lt scores, namely the d-meld and balance of risk (bar), showed to well predict early post-lt survival. similarly, some post-lt scores were able to estimate ead, and, thereby, to predict the probabilities of early re-lt and patient death. interestingly, all of these scores, especially those based on pre-lt variables, resulted in a scarce prediction of long-term (five-year) survivals. recently, the comprehensive complication index (cci) has been developed in order to better capture complication rates after surgery. some reports reported its excellent prognostic ability in different fields. however, up to now, no studies investigated the role of cci concerning long-term prognostication of graft loss in lt. this study aims at constructing an easy-to-use score system based on the combination of a small number of pre- and immediately post-lt independent variables, in order to accurately predict five-year post-lt graft survival. both external and internal validations of the score were performed.

Eligibility criteria:
inclusion criteria: * first transplant * adult (\>18 years) exclusion criteria: * living donation * re-transplant * combined transplant * domino transplant * paediatric transplant
study evaluating sirolimus in the treatment of kidney transplant

Conditions: Kidney Failure; Kidney Diseases

Summary: the aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.


Eligibility criteria:
inclusion criteria: * renal transplantation * biopsy-confirmed chronic rejection * treatment with mofetil mycophenolate among cyclosporine or tacrolimus exclusion criteria: * transplant of any organ other than the kidney * current important infection * acute rejection within 12 weeks prior to inclusion

Keywords: kidney failure kidney transplant graft rejection kidney transplantation
sbrt combined with camrelizumab and apatinib for conversion therapy in patients with unresectable hepatocellular carcinoma.

Conditions: Unresectable Hepatocellular Carcinoma (HCC)

Summary: •this is a randomized, open-label, multi-center, phases 2 and phase 3 trial to evaluate the efficacy and safety of sbrt combined with camrelizumab and apatinib as conversion therapy versus camrelizumab combined with apatinib as first-line therapy for unresectable hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * signed informed consent form (icf). * aged 18 years or older. * hepatocellular carcinoma confirmed by histology/cytology. cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the american association for the diagnosis of liver diseases (aasld). * barcelona clinic liver cancer stage b or c disease, which was not amenable to radical surgery. * ecog performance status of 0 or 1. * child-pugh class of a. exclusion criteria: * known hepatocholangiocarcinoma, sarcomatoid hcc, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except hcc within 5 years or simultaneously. * existence of active autoimmune disease or history of autoimmune disease and may relapse. * patients with innate or acquired immune deficiency (e.g., hiv infection). * known allergies to study drugs or excipients.
the effect of certolizumab pegol on mri synovitis and bone edema in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine whether certolizumab pegol can rapidly reduce the inflammatory changes and inhibit erosions on hand and wrist mri in patients with active moderate to severe rheumatoid arthritis.

the primary objective of this study is to evaluate the efficacy of csp used in combination with mtx in patients with active moderate to severe ra by evaluating change from baseline in synovitis and bone edema mri scores at week 6.

Eligibility criteria:
inclusion criteria: * moderate to severe ra (das \> 4.4) * at least two swollen and tender joints in one of the hand/ wrist * patients must have failed at least one non-biologic or biologic dmards * currently receiving mtx therapy exclusion criteria: * concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment

Keywords: certolizumab pegol magnetic resonance imaging rheumatoid arthritis rapid 3
can resistance enhance selection of treatment? (crest)

Conditions: HIV Infection

Summary: to compare two commercially available platforms for assessment of hiv drug resistance to determine which provides superior virological results. we hypothesise that one test will be significantly superior to the other.


Eligibility criteria:
inclusion criteria: * hiv infected patients taking combination antiretroviral therapy, with plasma hiv rna\> 2000copies/ml, who were willing to change arvs and who provided informed consent. exclusion criteria: * patients who were arv naïve, who were experiencing an acute illness or judged to be unable to comply with the protocol requirements.

Keywords: hiv drug resistance testing treatment experienced